Fluid transfer device

- EMD Millipore Corporation

A disposable device for the sterile transfer of fluids, such as liquids or gases, includes a body, a bore formed through at least a portion of the interior of the body, and a linearly moveable plunger contained within the bore. The body is formed from a rotating section and a stationary section. Partial rotation of the rotating section around a portion of the stationary section and the plunger drives the plunger linearly within the bore, opening and closing the device. The plunger includes at least a first and a second opening, and a fluid channel in the interior of the plunger connecting the first and second openings forming a fluid pathway to downstream components when the device is open. A termination component at one end of the plunger connects to a downstream component. A flange at one end of the body attaches to an upstream component. When the device is closed, the upstream end of the plunger is in alignment with the upstream flange of the body, forming a steamable sterilized in place face and a sterile barrier.

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Description

This application is a continuation of U.S. application Ser. No. 13/827,747 filed Mar. 14, 2013, which is a continuation of U.S. application Ser. No. 12/291,814 filed Nov. 13, 2008 (U.S. Pat. No. 8,690,120 issued Apr. 8, 2014), which claims priority to U.S. Provisional Application No. 61/003,364 filed Nov. 16, 2007, the disclosures of which are herewith incorporated by reference in their entirety.

BACKGROUND OF THE INVENTION

In the pharmaceutical, biotechnology and even food, beverage and cosmetic industries, it is often desired to provide large scale processing systems that are capable of handling fluids in a sterile manner. These large scale processing systems are designed to prevent unwanted and often dangerous organisms, such as bacteria, as well as unwanted and potentially harmful environmental contaminants, such as dust, dirt and the like from entering into the process stream and/or end product. In order to prevent these types of outside contaminants from entering these systems it is desirable to have a completely sealed processing system. However, completely closed processing systems are not always possible since there is a need for the introduction or removal of materials from the process stream in order to add components of the product, such as media or buffers to a bioreactor; withdraw samples from the process stream to check for microbial contamination, quality control, process control, etc; and to collect the product into its final container such as vials, syringes, sealed boxes, bottles and the like.

Traditionally, processing systems have been made of stainless steel, wherein the stainless steel systems are exposed to live steam before use, and then cleaned with chemicals such as caustic solutions after use, to ensure that all contaminants and the like are removed. Steaming is the most effective means of sterilization. The use of steam in a set system is known as steaming in place or SIP. Saturated steam carries 200 times the BTU heat transfer capacity of heated air because of the latent heat released by the steam as it changes from vapor to liquid.

However, several disadvantages exist with the use of steam. Any connection to, or opening of, the processing system made after the system has been steamed in place is an aseptic (but not sterile) connection or opening. This increases the risk of contamination of the entire system. Typically alcohol wipes or an open flame are used to clean the components intended to be connected to the system, (e.g., connecting a sample collection bag to a system after SIP has occurred) and thus minimizes the risk of contamination.

Also, the high temperatures and pressure differentials associated with steam make the selection of filter materials and other components difficult and limited. Additionally, accidental pressure differential at high temperatures can cause a filter, membrane or other non-steel component to fail.

Processing systems that are reused need to undergo rigorous testing and validation to prove to the necessary regulatory authorities that the system is sterile before each use. The validation process and the required cleaning regiment of a previously used system are expensive and time consuming, typically taking up to 1 to 2 years for approval. In addition, certain components are difficult to adequately clean after use in preparation for their next use. Since manufacturers are often looking for ways to reduce both the costs and the time to market for their products, one possible approach at reducing costs and time to market for a product is to adopt an all disposable system that is set up in a sterile fashion, used once and then discarded.

Another possible approach to alleviating the time and expense associated with a systems' cleaning regiment is the use of disposable components for certain reusable components that are more expensive and/or time consuming to clean than other components.

Additionally, disposable components that are used in place of time consuming to clean reusable components should be easy to remove and replace. For example, the ease with which large scale disposable fluid transfer devices, such as valves or connectors, can be removed and replaced, and the manner in which large scale disposable assemblies are integrated into traditional stainless steel processing systems via disposable fluid transfer devices, have the potential to reduce processing costs and improve the efficacy and productivity of these systems.

SUMMARY OF THE INVENTION

The present invention relates to a sterile transfer device for fluids, wherein the fluids are liquids or gases. In one embodiment, the transfer device includes a body, a bore formed through at least a portion of the interior of the body, and a linearly moveable plunger contained within the bore. In one embodiment, the bore is a lateral central bore formed through the entire interior length of the body, wherein the body is formed from a rotating first section and a stationary second section, such that the first section rotates around a portion of the stationary second section and the plunger. The rotation of the first section engages the stationary second section and the plunger, driving the plunger linearly within the bore, thereby actuating (i.e., opening/closing) the fluid transfer device. One end of the body includes a connecting component for attaching the device to an upstream component, and one end of the plunger includes a connecting component for attaching the device to a downstream component. In one embodiment, the plunger includes first and second openings, and a fluid channel in at least a portion of the interior of the plunger, connecting the first and second openings, thereby forming a pathway for fluid to travel from an upstream component to a downstream component when the fluid transfer device is in the opened position. When the device is in the closed position, the first end of the plunger is in alignment with the connecting component at one end of the body, forming a seal against fluid in the upstream component from entering the device, thereby forming a steamable face and a sterile barrier against environmental contaminants for any downstream component.

In another embodiment, the present invention relates to a fluid transfer device in use, wherein the device is in the closed position and attached to a downstream component(s), such as tubing connected to a bag, at one end of the plunger at a connecting component. Next, the entire fluid transfer device and the attached downstream component are sterilized, such as with gamma radiation or the like. Next, an upstream component (s), such as a filter outlet, a tank outlet, or a pipe is attached to a face formed at another end of the device when the device is the closed position. This face is formed when a connecting component at one end of the body is in alignment with the bottom portion. Next, the upstream component attached to the device at the face, are then steam sterilized in place (SIP). Finally, the device is then opened when needed, establishing a sterile pathway for fluids traveling from the upstream component through the fluid transfer device to the downstream component.

In another embodiment, the present invention relates to a disposable fluid transfer device for use in traditional stainless steel processing systems or disposable processing systems. The fluid transfer device of the present invention provides a steam sterilizing mating point between the transfer device and an upstream component, and a sterilizable mating point between the transfer device and a downstream component. Additionally, the transfer device can be conveniently removed from the processing system and discarded after use, thereby not requiring a cleaning regiment.

In another embodiment, the present invention also relates to disposable large scale fluid transfer devices for the integration of large scale disposable upstream and/or downstream assemblies into traditional stainless steel systems or disposable systems. The fluid transfer device of the present invention provides a steam sterilizing mating point between the transfer device and an upstream component, and a sterilizable mating point between the transfer device and a downstream component. Additionally, the transfer device can be conveniently removed from the processing system and discarded after use, thereby not requiring any cleaning regiment.

IN THE DRAWINGS

The present invention will become more fully understood from the detailed description given herein below and the accompanying drawings which are given by way of illustration only, and thus are not limitative of the present invention, and wherein:

FIG. 1a is a cross sectional view of an embodiment of the present invention in a closed position;

FIG. 1b is a cross section taken along line 1b-1b;

FIG. 2 is a cross sectional view of the embodiment of the present invention of FIG. 1 in an opened position;

FIGS. 3a and 3b are perspective views of additional embodiments of the present invention of FIG. 1, along with alternative embodiments of upstream and downstream attachment components; and

FIGS. 4a and 4b are perspective views of an embodiment of the present invention of FIG. 1.

DETAILED DESCRIPTION OF THE INVENTION

In general, the present invention is a sterile fluid transfer device, such as a flow-through connector or valve, wherein the fluids are liquids and/or gases. In one embodiment, the fluid transfer device has a body, a bore located in the interior of the body, and a linearly movable plunger contained within the bore. The body is formed from a first and a second section. The first section has a first end containing a first opening and a termination attachment component, such as a flange or the like surrounding the first opening for attaching the body to an upstream component(s). The second section has a second end containing a second opening, wherein the bore connects the first and second openings. The first section rotates around a portion of the second section.

The linearly movable plunger includes a first end containing a first opening, a second end containing a second opening, a fluid channel located in the interior of the plunger connecting the first and second openings of the plunger. In one embodiment, the plunger includes a component for inhibiting its rotation, while promoting its linear movement within the bore during rotation of the first section of the body when the device is actuated (i.e., opened/closed).

The fluid transfer device is in the closed position when the first end of the plunger is in alignment with the termination attachment component surrounding the first opening of the body, thereby forming a fluid resistant seal and a steamable face. The device is in the opened position when the first end of the plunger is not in alignment with the termination attachment component surrounding the first opening of the body, thereby permitting fluids to enter the device from an upstream component.

To the extent that the same reference numbers apply to the figures they have been kept the same.

One embodiment of the invention shown in FIGS. 1a and 2 includes a device 12 having a body 14 having a bore 20 formed through at least a portion of the interior of the body, and a generally hollow moveable plunger 62 contained within the bore. Bore 20, as shown, is a lateral central bore formed through the entire interior length of the body 14. Body 14, as shown, is formed from two sections, a rotating first section 26 and a stationary second section 28. First section 26 rotates partially around a portion of the stationary second section 28 and plunger 62. Bore 20, as shown, is formed of two sections, a rotating bore section 34 which generally corresponds to the inner wall of rotating first section 26, and a stationary bore section 36 which generally corresponds to the inner wall of stationary second section 28. In the embodiment depicted in FIGS. 1a and 2, each of the bore sections (34, 36) has different diameters. As will be described in greater detail herein, device 12 is actuated (i.e., opened/closed) when first section 26 of the body is rotated, engaging second section 28 of the body and plunger 62, driving the plunger linearly within the bore 20, thereby actuating (i.e., opening and closing) the device.

As shown in FIGS. 1a and 2, the first section 26 of the body 14 is generally hollow and has an opening 18 at one end for receiving the plunger. As shown in FIGS. 1a and 2, the first section 26 includes a protruding lip or edge component 38 that is rotatably engaged by a stationary wall receiving groove 44 on the outer stationary 28 wall section.

In FIG. 2, the first section 26 also includes an inner wall having a stationary wall engaging section 40, and forms a rotating bore section 34 having four sections. There is a first rotating bore set diameter 34a, a transition rotating bore section 34b, a second rotating bore diameter 34c and a third rotating bore diameter 34d. The first set diameter 34a engages the plunger as it moves linearly within the bore 20. The transition section 34b is arranged between the first and second diameters (34a, 34c) and has an outwardly tapering diameter along its length. The diameter of the transition section 34b is preferably a linear outward progression from the first diameter section 34a, wherein the diameter of the transition section 34b adjacent the first diameter 34a is equal to the first diameter 34a, and the diameter of the transition section 34b adjacent the second diameter 34c is equal to the diameter 34c. The third diameter 34d is preferably less than diameter 34c and preferably greater than the diameter 34a.

As shown in FIGS. 1a and 2, the stationary second section 28 of the body 14 is generally hollow and has an opening 16 at one end that permits a fluid provided from an upstream source (not shown) to pass through it when opened. The opening 16 also receives the bottom 63 of the plunger when the device is closed. The stationary section 28 includes an outer wall component 42 for rotatably engaging the inner wall section 40 of the rotating section 26. As shown in FIGS. 1a and 2 the inner wall of the second section 28 forms the stationary bore section 36 having four sections. There is a first stationary bore diameter 36a, a first transition stationary bore section 36b, a second stationary bore diameter 36c, and a second transition stationary bore section 36d. The first bore diameter 36a is less than the second bore diameter 36c. The second bore diameter 36c is a set diameter. The first transition bore section 36b is arranged between the first and second bore diameters (36a, 36c) and has an outwardly tapering diameter along its length. The diameter of the first transition section 36b is preferably a linear outward progression between the first and second bore diameters (36a, 36c). The diameter of the first transition section 36b adjacent the first diameter 36a is equal to the diameter 36a, and the diameter of the first transition section 36b adjacent the second diameter 36b is equal to the diameter 36b.

As shown in FIGS. 1a and 2 plunger 62 has three general regions comprising a first, second and third region. The first region 24 has a diameter equal to or less than the first rotating bore set diameter 34a. The second region 25 has a diameter equal to or less than the second stationary bore diameter 36c. The third region 29 has a diameter equal to or less than that of the first stationary bore diameter section 36a. The plunger has a bottom component 63 at the end of the third region 29 for blocking the opening 16 of the stationary section 28 when the device is in the closed position, as shown in FIG. 1a. One embodiment of the invention as depicted in FIGS. 1a and 2 includes a static diaphragm seal 60 located on the bottom 63 of the plunger forming a tight fluid resistant seal between the outer wall 61 of the bottom end 63 of the plunger, and the inner wall 82 of stationary section 28 of the body forming the opening 16.

Plunger 62 also has at least two openings, a first opening 64 and a second opening 66. A channel 68 is located in the interior of the plunger and connects the first and second openings (62, 64), thereby forming a fluid pathway to a downstream component. As shown in FIGS. 1a and 2, the first opening 64 is located in the first portion 24 of the plunger, and the second opening 66 is located in the second portion 25 of the plunger. In other embodiments, plunger 62 can contain additional openings and interior fluid pathways. In one preferred embodiment, the plunger contains at least openings in the second portion 25. (not shown)

One embodiment of the invention as depicted in FIGS. 1a and 2 includes plunger 62 having a component for inhibiting the rotation of the plunger within the bore, while promoting linear movement of the plunger when the fluid transfer device 12 is actuated (i.e., opened/closed). One embodiment for accomplishing the linear movement of the plunger, as shown in FIGS. 1a and 2, depicts the plunger having a pair of wings (74, 76), fins, or the like, that extend from the outer wall of the plunger towards the inner wall of the second section 28 of body 14. Second section 28 has a component for interacting with wings (74, 76) comprising two corresponding pairs of parallel slots (70, 72), grooves, or the like located on the inner wall of the section 28 for receiving the wings (74, 76) in order to restrict the rotation of the plunger 62 and promote the linear movement of the plunger within the bore 20. Wings (74, 76) ride between each corresponding pair of slots (70, 72) thereby facilitating the linear movement of the plunger within the bore during actuation (opening/closing) of the device 12.

As shown in FIG. 1a, when device 12 is in the closed position the bottom end 63 of the plunger is in alignment with flange 80, forming a face 90, and providing the device with a steamable surface and a sterile barrier against the environment for the interior of the device, plunger and any downstream components. In the closed position, the bottom end 63 of the plunger does not permit fluid to enter opening 16 in the device from an upstream component (not shown), thereby preventing any fluid from traveling downstream.

As shown in FIG. 2, device 12 is in the opened position when the plunger 62 is linearly moved within the lateral bore 20 by the rotation of section 26 of the body 14, such that the bottom end 63 of the plunger 62 is moved back from the flange 80, permitting fluid, depicted by an arrow, to travel from an upstream component (not shown), through opening 16 in section 28 of the body. The fluid then travels through the second hole 66 of the plunger, into the interior channel 68 of the plunger, out opening 64, and into a downstream component. (not shown) Plunger 62 is not permitted to rotate within the bore during the rotation of the rotating section 26, but is forced to move linearly by wings (74, 76) of the plunger located within the parallel slots (70, 72) on the inner wall of section 28.

Additionally, by preventing the plunger from rotating when the device is opened or closed, the problem of torsion between device 12 and an attached upstream or downstream component can be averted, since it is not necessary to twist or turn the upstream or downstream components, or the device, when removing or actuating the device since the plunger moves within the bore linearly, and not rotationally.

As shown in FIGS. 3a, 3b, 4a, and 4b, the plunger 62 can contain one or more cams 56 (only one shown) that ride in one or more cam slots 58 (only one shown) located in the rotating section 26 of the body 14. The arrangement of the cam 56 and slot 58 acts to limit the length the plunger 62 travels linearly within the bore 20 when the device is actuated (opened or closed). When device 12 is in the closed position, as shown in FIG. 4a, the cam 56 sits in the closed position of the cam slot 58. When device 12 is in the opened position, as shown in FIG. 4b, the cam 56 sits in the opened position of the calm slot 58. The arrow in FIG. 4b depicts the rotational movement of rotating section 26 and cam slot 58.

As shown in FIGS. 3a and 3b, device 12 has at one end of the stationary section 28 of the body a component for attaching the device to an upstream component. In this embodiment, a flange 80 attaches to a flange 88 of an upstream component. As shown in FIG. 3a, the end of the first plunger region 24 includes, in this embodiment, a barb termination 92 for connecting the device to a downstream component, in this instance, tubing 72.

As shown in FIG. 3b, the end of first plunger portion 24 includes, in this embodiment, a termination flange 94 for connecting the device to a downstream component, in this embodiment, a termination flange 78.

By way of example, the downstream components attached to the device by the termination connection feature on the plunger can be plastic tubing 72 and the like, as shown in FIG. 3a, attached to a plastic bag or other type of known receptacle (not shown), and the like.

By way of example, the upstream component attached to the device can be a pipe, a stainless steel or disposable plastic tank having an outlet, and the like, having an attachment flange 88 (as depicted in FIGS. 3a and 3b), or any other mode of attachment for connecting components to transfer devices as are commonly known in the art. For example, flange 80 on device 12 can be connected to an upstream component or pipe by a clamp such as a Tri-Clover™ fitting, Ladish™ fitting, ClickClamp™ clamp and the like.

When using device 12 to fill a downstream component such as a bag, or any collection vessel attached the tubing 72, the device is opened by rotating section 28 of the body, which moves the plunger 62 linearly (see FIG. 4b) away from the face 90, permitting fluid to enter opening 16 (see FIG. 2) and to eventually flow out the opening exit 64 through tube 72, and into a bag, or any collection vessel or other fluid transport device. (not shown) Once a bag is full, the rotating section 28 is rotated in the opposite direction to move the plunger linearly again, this time in the opposite direction, in order to seal the opening 16 closed (see FIG. 1) to the fluid from an upstream component. By way of example, an attached bag can then be closed off via a clamp or hemostat (not shown) and removed for further processing or use.

One or more seals are arranged along the length and end of the plunger 62 to form a fluid tight seal between various portions of the plunger 62 and the bore 20 when the device is in the closed or opened positions. As shown in FIGS. 1a and 2, seals 60 and 54 are partly contained within grooves 48, and 46 and 44 respectively.

As shown in FIGS. 1a and 2, the seals may be mounted on the plunger 62. However, if desired, a different configuration of seals and their placements can also be used. For example, FIGS. 1a and 2 show seals 46 and 60 formed in grooves on the plunger 62. A linear or gland seal 51 is retained within a groove 50 on the inner wall of the stationary bore section and within a groove 46 on the plunger 62.

Other embodiments of the present invention are also contemplated, such as molding the device 12 into a disposable plastic container such as a disposable process bag for the manufacture and transfer of biotech products and the like. Such bags are readily available from companies such as HyClone (which is part of Thermo Fisher Scientific) of Logan, Utah and Stedim Biosystems of Concord, Calif.

Since the fluid transfer device 12 is preferably provided in a sterile condition, (i.e., the interior of the system and any component connected downstream of the device is pre-sterilized such as with gamma radiation, ethylene gas or the like and shipped in a sterile condition), some type of use indicator (not shown) may be helpful, and capable of informing a user when a system has been used. As an alternative, or in addition to any of the indicator mechanisms discussed above, a shrink wrap indicator (not shown) may be located over the device or at least over the rotating first section of the device to indicate whether the device had been used.

The device is preferably formed a plastic material and may be formed by machining the body and plunger assemblies and then applying the necessary seals and the like, or preferably by molding the body and the plunger separately and assembling them together with the necessary seals and other components. Alternatively, the body may be molded into two separate halves and assembled by attaching the plunger component with the necessary seals and other components to one half of the body, followed by the attaching the remaining half of the body to the plunger, necessary seals, other components, and the first half of the body.

The device may be made of any plastic material capable of withstanding in line steam sterilization. The temperature and pressure of such sterilization is typically about 121° C. and 1 bar above atmospheric pressure. In some instances, it may be desirable to use even harsher conditions such as 142° C. and up to 3 bar above atmospheric pressure. The body and at least the face of the plunger should be capable of withstanding these conditions. Preferably, the entire device is made of the same material and is capable of withstanding these conditions. Suitable materials for this device include but are not limited to PEI (polyetherimide), PEEK, PEK, polysulphones, polyarlysulphones, polyalkoxysulphones, polyethersulphones, polyphenyleneoxide, polyphenylenesulphide and blends thereof. Alternatively, one can make the face portion from ceramic or metal inserts alone, or that are overmolded with a plastic cover. One can also form a polymeric face with a metal outer layer using plasma coating processes.

The seals of the present invention can be made of a variety of materials typically used for making resilient seals. These materials include but are not limited to natural rubber, synthetic rubbers, such as silicone rubbers, including room temperature vulcanizable silicone rubbers, catalyzed (such as by platinum catalysts) silicone rubbers and the like, thermoplastic elastomers such as SANTOPRENE® elastomers, polyolefins such as polyethylene or polypropylene, especially those containing gas bubbles introduced either by a blowing agent or entrained gas such as carbon dioxide, PTFE resin, thermoplastic perfluoropolymer resins such as PFA and MFA resins available from Ausimont, USA Inc., of Thorofare, N.J. and E.I. DuPont de Nemours of Wilmington, Del., urethanes, especially closed cell foam urethanes, KYNAR® PVDF resin, VITON® elastomer, EPDM rubber, KALREZ resin and blends of the above.

Suitable materials for molded in place seals can be curable rubbers, such as room temperature vulcanizable silicone rubbers, thermoplastic elastomers such as SANTOPRENE® elastomers, polyolefins such as polyethylene or polypropylene, especially those containing gas bubbles introduced either by a blowing agent or entrained gas such as carbon dioxide and elastomeric fluoropolymers.

Other materials used in the devices should also be FDA grade components such as FDA grade silicones, PTFE resins and the like.

The present invention provides a sterile and steam sterilizable in place connecting device for fluid transfer. It may be single actuation (one open one close) or it may be multiple actuations with a single sterile connection (multiple openings and closings) so long as the sterile connection upstream and downstream is maintained. Additionally, with the use of multiple seals or seals of long length, one is able to ensure that the sterility of the device is maintained even with multiple actuations.

Many modifications and variations of this invention can be made without departing from its spirit and scope, as will be apparent to those skilled in the art. The specific embodiments described herein are offered by way of example only and are not meant to be limiting in any way. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the invention being indicated by the following claims.

Claims

1. A fluid transfer device comprising:

a body;
an elongate passage having an interior wall and extending through the body and having a proximal end and a distal end;
a longitudinally displaceable plunger disposed in and extending along the passage, the plunger having a proximal end and a distal end and having a first position displaced toward the distal end of the passage and a second position displaced toward the proximal end of the passage;
at least one static diaphragm seal mounted on the proximal end of the plunger to form a fluid tight seal between the plunger and the passage, said static diaphragm seal remaining intact during movement of said plunger from said first position to said second position and back to said first position;
a gland seal; and
a fluid transfer opening positioned between the proximal end of the plunger and the distal end of the plunger;
wherein the body comprises a first section and a second section, wherein rotation of the first section relative to the second section causes longitudinal displacement of the plunger, and wherein the longitudinal displacement of the plunger towards its first position opens the passage to form a substantially aseptic fluid pathway from an upstream component to a downstream component through the fluid transfer opening and a channel in the interior of the plunger; and
wherein the gland seal is arranged along a length of the plunger, a first portion of the gland seal being retained within a groove on a surface of the first section of the body and a second portion of the gland seal being retained within a groove on the plunger, and wherein the gland seal stretches to accommodate the displacement of and maintain a seal about the plunger.

2. The device of claim 1, wherein the diaphragm seal is attached to the proximal end of the plunger and seals the passage at the proximal end thereof.

3. The device of claim 2, wherein the diaphragm seal is disposed at least partially inside the proximal end of the passage prior to displacement of the plunger.

4. The device of claim 1, wherein the gland seal seals the passage at a location intermediate the diaphragm seal and the distal end of the passage.

5. The device of claim 1, wherein the plunger extends through and is sealingly secured to the gland seal.

6. The device of claim 1, further comprising a substantially aseptic tank mount.

7. The device of claim 1, wherein the at least one seal is constructed of a silicone elastomer.

8. The device of claim 1, wherein the at least one seal is constructed of a solvent resistant fluoroelastomer.

9. The device of claim 1, wherein the body comprises a substantially cylindrical outer portion, and at least one alignment slot for the plunger.

Referenced Cited

U.S. Patent Documents

214367 April 1879 Colvin
229695 July 1880 Granger
988378 April 1911 Olson
1503132 July 1924 Prator
1585163 May 1926 Milner
1831457 November 1931 Larsen
1852445 April 1932 Calkins et al.
2012836 August 1935 Talbot et al.
2122991 July 1938 Polston
2240888 May 1941 Hageline
2426808 September 1947 Auer
2642256 June 1953 Stehlin
2712881 July 1955 Mathisen
2736201 February 1956 Ohlsen et al.
2767587 October 1956 Perkins
2776473 January 1957 Dailey et al.
2779350 January 1957 Owens
2844964 July 1958 Guibert
2859932 November 1958 Mackal
2865394 December 1958 Presley
2872817 February 1959 Pitts
2952269 September 1960 Stehlin
2994224 August 1961 Brown
3038485 June 1962 Hosek
3039482 June 1962 Goldberg
3097532 July 1963 Brown et al.
3219047 November 1965 Kircher, III et al.
3223100 December 1965 Koenig et al.
3244376 April 1966 Thompson
3260120 July 1966 Stilwell
3276447 October 1966 Hamilton
3319622 May 1967 Shiner
3367626 February 1968 Stern
3390677 July 1968 Razimbaud
3424181 January 1969 Morse
3479880 November 1969 Mutter et al.
3525350 August 1970 Hosek
3621719 November 1971 Goodman et al.
3633621 January 1972 Myers
3638499 February 1972 Saint-Andre
3678959 July 1972 Liposky
3696932 October 1972 Rosenberg
3736099 May 1973 Begg et al.
3747411 July 1973 McDermott et al.
3776042 December 1973 Werra et al.
3779082 December 1973 Galloway
3802782 April 1974 Natelson
3838707 October 1974 Wachowitz, Jr.
3848581 November 1974 Cinqualbre et al.
3858449 January 1975 Singer
3921456 November 1975 Newcomb, Jr. et al.
3985332 October 12, 1976 Walker
4015631 April 5, 1977 Hayes
4018059 April 19, 1977 Hatch
4034775 July 12, 1977 Slagel
4055179 October 25, 1977 Manschot et al.
4061709 December 6, 1977 Miller et al.
4064003 December 20, 1977 Newton
4094197 June 13, 1978 Harris et al.
4207922 June 17, 1980 Andrieux et al.
4244224 January 13, 1981 Conn
4294247 October 13, 1981 Carter et al.
4296759 October 27, 1981 Joslin et al.
4325401 April 20, 1982 Ukai et al.
4346609 August 31, 1982 Diesel
4353386 October 12, 1982 Slagel
4378824 April 5, 1983 Carder
4423641 January 3, 1984 Ottung
4423642 January 3, 1984 Kuboichi
4454772 June 19, 1984 Brunner et al.
4458543 July 10, 1984 Mieth
4479393 October 30, 1984 Shores
4525127 June 25, 1985 Welker
4527436 July 9, 1985 Jones
4537593 August 27, 1985 Alchas
4557151 December 10, 1985 Welker
4569236 February 11, 1986 Kitchen et al.
4580452 April 8, 1986 Masson
4584887 April 29, 1986 Galen
4587856 May 13, 1986 Otis
4587887 May 13, 1986 Shibayama et al.
4622457 November 11, 1986 Bradley et al.
4630847 December 23, 1986 Blenkush
4657027 April 14, 1987 Paulsen
4669312 June 2, 1987 Maurer
4669321 June 2, 1987 Meyer
4704910 November 10, 1987 Conrad
4826055 May 2, 1989 Stull
4836236 June 6, 1989 Ladisch
4838877 June 13, 1989 Massau
4861239 August 29, 1989 Simmons et al.
4889692 December 26, 1989 Holtzman
4913185 April 3, 1990 Mattei
4941517 July 17, 1990 Galloway
4942901 July 24, 1990 Vescovini
4944875 July 31, 1990 Gaignet
4997108 March 5, 1991 Hata
5058619 October 22, 1991 Zheng
5095765 March 17, 1992 Filbey et al.
5117872 June 2, 1992 Yie
5158558 October 27, 1992 Melker et al.
5161417 November 10, 1992 Strong et al.
5177872 January 12, 1993 Lewis et al.
5246204 September 21, 1993 Ottung
5285999 February 15, 1994 Scholz
5296197 March 22, 1994 Newberg et al.
5360413 November 1, 1994 Leason et al.
5375477 December 27, 1994 Neill et al.
5398557 March 21, 1995 Shimizu et al.
5435339 July 25, 1995 Hayes
5452746 September 26, 1995 Hoobyar et al.
5463908 November 7, 1995 Rosolia
5468388 November 21, 1995 Goddard et al.
5474546 December 12, 1995 Ambrisco et al.
D366935 February 6, 1996 Arthun et al.
5520218 May 28, 1996 Hlavinka et al.
5525301 June 11, 1996 Newberg et al.
5533983 July 9, 1996 Haining
5535635 July 16, 1996 Shaw
5542305 August 6, 1996 Hollinger
5549568 August 27, 1996 Shields
5585576 December 17, 1996 Jaeger
D381067 July 15, 1997 Karmalm
5730418 March 24, 1998 Feith et al.
5747708 May 5, 1998 Weiberth
5755155 May 26, 1998 Buesing
5766462 June 16, 1998 Jones
5786209 July 28, 1998 Newberg et al.
5820614 October 13, 1998 Erskine et al.
5829425 November 3, 1998 Woods et al.
5865423 February 2, 1999 Barber
5868433 February 9, 1999 Matkovich
5881997 March 16, 1999 Ogawa
5885255 March 23, 1999 Jaeger et al.
5897526 April 27, 1999 Vaillancourt
5911252 June 15, 1999 Cassel
5948998 September 7, 1999 Witte et al.
6009684 January 4, 2000 Buesing
6030578 February 29, 2000 McDonald
6032543 March 7, 2000 Arthun et al.
6056003 May 2, 2000 Madsen
6068617 May 30, 2000 Richmond
6096011 August 1, 2000 Trombley et al.
6133022 October 17, 2000 Newberg
6145810 November 14, 2000 Connoly et al.
6156025 December 5, 2000 Niedospial, Jr. et al.
6162206 December 19, 2000 Bindokas et al.
6170800 January 9, 2001 Meloul et al.
6196522 March 6, 2001 Yuen et al.
6210372 April 3, 2001 Tessmann et al.
6221041 April 24, 2001 Russo
6237639 May 29, 2001 Jougla et al.
6254773 July 3, 2001 Biltoft
6273869 August 14, 2001 Vaillancourt
6306191 October 23, 2001 McInerney
6314987 November 13, 2001 Hay
6345640 February 12, 2002 Newberg
6345645 February 12, 2002 Kenna et al.
D454173 March 5, 2002 Almasian et al.
6354466 March 12, 2002 Karpisek
6357306 March 19, 2002 Jaeger
6360794 March 26, 2002 Turner
6386137 May 14, 2002 Riche
6390127 May 21, 2002 Schick
6477906 November 12, 2002 Peterson
6516677 February 11, 2003 Suter
6558365 May 6, 2003 Zinger et al.
6568844 May 27, 2003 Arthun et al.
6601823 August 5, 2003 Newberg
6623631 September 23, 2003 Graus et al.
6648006 November 18, 2003 Ostergaard
6672561 January 6, 2004 Kerg et al.
6699229 March 2, 2004 Zinger et al.
6715624 April 6, 2004 Brockwell
6779575 August 24, 2004 Arthun
6860162 March 1, 2005 Jaeger
6871669 March 29, 2005 Meyer et al.
6902144 June 7, 2005 deCler
6916012 July 12, 2005 Newberg
7137974 November 21, 2006 Almasian et al.
7195181 March 27, 2007 Steingass et al.
7195182 March 27, 2007 Fischer et al.
7272981 September 25, 2007 Bigalke
7273550 September 25, 2007 Gutman et al.
7293475 November 13, 2007 Furey et al.
7293477 November 13, 2007 Furey et al.
7350535 April 1, 2008 Leipold et al.
7473360 January 6, 2009 Hoffman et al.
7488446 February 10, 2009 Meyer et al.
7578205 August 25, 2009 Belongia
7578936 August 25, 2009 Gaignet et al.
7597683 October 6, 2009 Myhrberg et al.
7661437 February 16, 2010 Schulz
RE41169 March 30, 2010 Arthun
7722733 May 25, 2010 Tomasetti et al.
7753340 July 13, 2010 Liepold et al.
7815362 October 19, 2010 Myhrberg et al.
7921740 April 12, 2011 Furey et al.
7927316 April 19, 2011 Proulx et al.
7959754 June 14, 2011 Arthun
8029023 October 4, 2011 Arthun et al.
8167480 May 1, 2012 Myhrberg et al.
8281961 October 9, 2012 Martin
8517998 August 27, 2013 Proulx et al.
8539988 September 24, 2013 Guedon
8544497 October 1, 2013 Hillier et al.
8549935 October 8, 2013 Furey et al.
8562572 October 22, 2013 Proulx et al.
8579871 November 12, 2013 Proulx et al.
8646342 February 11, 2014 Furey et al.
8690120 April 8, 2014 Hartnett et al.
8915264 December 23, 2014 Hillier et al.
8919365 December 30, 2014 Hillier et al.
9028779 May 12, 2015 Olivier
9120585 September 1, 2015 Olivier
9150825 October 6, 2015 Guedon
9279100 March 8, 2016 Guedon
9296983 March 29, 2016 Guedon
9482351 November 1, 2016 Proulx et al.
20010022353 September 20, 2001 Takeda
20020024034 February 28, 2002 Hall
20020129858 September 19, 2002 Meyer et al.
20030188588 October 9, 2003 Jaeger
20050006617 January 13, 2005 Leys
20050016620 January 27, 2005 Proulx et al.
20050035597 February 17, 2005 Bamberger et al.
20050090797 April 28, 2005 Almasian et al.
20050132821 June 23, 2005 Furey et al.
20050150546 July 14, 2005 Liepold et al.
20050285066 December 29, 2005 Huang
20060081804 April 20, 2006 Cong
20060086922 April 27, 2006 Jensen et al.
20060091060 May 4, 2006 Gutman et al.
20060142730 June 29, 2006 Proulx et al.
20060201263 September 14, 2006 Furey et al.
20060211995 September 21, 2006 Myhrberg et al.
20060243942 November 2, 2006 Liepold et al.
20060272432 December 7, 2006 Belongia
20070106264 May 10, 2007 Proulx et al.
20070193375 August 23, 2007 Pandori et al.
20070212915 September 13, 2007 Strnad et al.
20070246674 October 25, 2007 Kiehne
20070253287 November 1, 2007 Myhrberg et al.
20080000820 January 3, 2008 Mitchell
20080022785 January 31, 2008 Furey et al.
20080087860 April 17, 2008 Vaillancourt et al.
20080103476 May 1, 2008 Schulte
20080185552 August 7, 2008 Myhrberg et al.
20080277878 November 13, 2008 Arthun et al.
20090019952 January 22, 2009 Furey et al.
20090054758 February 26, 2009 Dunseath
20090101575 April 23, 2009 Alburty et al.
20090229671 September 17, 2009 Hartnett et al.
20090250157 October 8, 2009 Arthun
20100123094 May 20, 2010 Zumbrum
20100133459 June 3, 2010 Zumbrum
20100154569 June 24, 2010 Guedon
20100158759 June 24, 2010 Olivier
20100290311 November 18, 2010 Myhrberg et al.
20100326212 December 30, 2010 Furey et al.
20110155258 June 30, 2011 Zumbrum
20110155274 June 30, 2011 Zumbrum
20110197989 August 18, 2011 Proulx et al.
20110250626 October 13, 2011 Williams et al.
20110253233 October 20, 2011 Hillier et al.
20130119289 May 16, 2013 Morris
20130199639 August 8, 2013 Hartnett et al.
20130306897 November 21, 2013 Hillier et al.
20130312492 November 28, 2013 Hillier et al.
20130334450 December 19, 2013 Proulx et al.
20140000753 January 2, 2014 Guedon
20140014230 January 16, 2014 Guedon
20140014231 January 16, 2014 Guedon
20140026989 January 30, 2014 Hillier et al.
20150217882 August 6, 2015 Olivier et al.

Foreign Patent Documents

101022875 August 2007 CN
2161702 June 1973 DE
3215799 November 1983 DE
3633431 April 1988 DE
3701250 July 1988 DE
8812723 December 1988 DE
19901654 August 2000 DE
10039196 February 2002 DE
60310700 October 2007 DE
0103396 March 1984 EP
0107579 May 1984 EP
0154002 September 1985 EP
0468957 February 1992 EP
0508749 October 1992 EP
0510355 October 1992 EP
0576380 December 1993 EP
0684050 November 1995 EP
0691492 January 1996 EP
0858589 August 1998 EP
1008359 June 2000 EP
1231699 August 2002 EP
1321699 June 2003 EP
1329210 July 2003 EP
1370788 December 2003 EP
1499382 January 2005 EP
1548420 June 2005 EP
1962076 August 2008 EP
2060835 May 2009 EP
1028455 January 1995 ES
943132 November 1963 GB
1381391 January 1975 GB
1418046 December 1975 GB
1463303 February 1977 GB
1479226 July 1977 GB
1511240 May 1978 GB
1573482 August 1980 GB
2327369 January 1999 GB
2365511 February 2002 GB
42-15498 September 1967 JP
44-4942 February 1969 JP
45-3461 February 1970 JP
49-112631 September 1974 JP
58-131802 September 1983 JP
59-38278 March 1984 JP
2-52667 February 1990 JP
2-71728 March 1990 JP
2-118276 May 1990 JP
2-121679 October 1990 JP
3-141948 June 1991 JP
6-10845 February 1994 JP
6-23045 February 1994 JP
6-78669 November 1994 JP
6-327772 November 1994 JP
7-51371 February 1995 JP
8-502339 March 1996 JP
8-168535 July 1996 JP
9-133248 May 1997 JP
9-154945 June 1997 JP
9-313896 December 1997 JP
9-512892 December 1997 JP
11-141713 May 1999 JP
11-270705 October 1999 JP
11-514741 December 1999 JP
2000-55792 February 2000 JP
2001-170188 June 2001 JP
2001-510088 July 2001 JP
2001-269401 October 2001 JP
2002-510996 April 2002 JP
2003-181248 July 2003 JP
2004-332797 November 2004 JP
2005-181336 July 2005 JP
2005-519825 July 2005 JP
2006-516723 July 2006 JP
2008-185218 August 2008 JP
2009-2965 January 2009 JP
2009-192540 August 2009 JP
4332106 September 2009 JP
649954 February 1979 SU
86/02450 April 1986 WO
90/12972 November 1990 WO
91/00215 January 1991 WO
94/08173 April 1994 WO
94/19086 September 1994 WO
95/30856 November 1995 WO
96/30076 October 1996 WO
97/16715 May 1997 WO
98/45188 October 1998 WO
98/50105 November 1998 WO
99/03568 January 1999 WO
99/06089 February 1999 WO
99/26580 June 1999 WO
00/78472 December 2000 WO
03/090842 November 2003 WO
03/090843 November 2003 WO
2005/012775 February 2005 WO
2006/022816 March 2006 WO
2006/026253 March 2006 WO
2008/042285 April 2008 WO
2008/048511 April 2008 WO
2008/136720 November 2008 WO
2010/008395 January 2010 WO
2010/008396 January 2010 WO
2010/122081 October 2010 WO
2012/114105 August 2012 WO
2013/011231 January 2013 WO

Other references

  • Final rejection dated Jun. 22, 2016 in co-pending U.S. Appl. No. 13/972,301.
  • Notice of Allowance dated Aug. 8, 2016 in co-pending U.S. Appl. No. 13/972,301.
  • International Search Report for PCT/US03/12927 dated Aug. 6, 2003, 3 pages.
  • International Search Report for PCT/US03/13073 dated Aug. 6, 2003, 7 pages.
  • International Search Report for PCT/US03/12924, dated Aug. 6, 2003, 2 pages.
  • International Search Report on PCT/US2008/070482, dated Apr. 16, 2009 , 2 pages.
  • Written Opinion of the International Searching Authority (Appln. No. PCT/US2008/070482, filed Jul. 18, 2008) dated Apr. 16, 2009, 4 pages.
  • International Search Report on PCT/US2011/021341, dated Sep. 27, 2011, 4 pages.
  • International Preliminary Examination Report for PCT/US03/12927 dated Feb. 11, 2004, 2 pages.
  • International Preliminary Examination Report for PCT/US03/12924 dated Jul. 8, 2004, 11 pages.
  • International Preliminary Report on Patentability (Appln. No. PCT/US2008/070482, filed Jul. 18, 2008) dated Jan. 27, 2011, pp. 1-6.
  • International Preliminary Report on Patentability (Appln. No. PCT/US2008/070488, filed Jul. 18, 2008) dated Jan. 27, 2011, pp. 1-6.
  • International Search Report and Written Opinion dated Apr. 3, 2014 in PCT application No. PCT/US2013/075460.
  • European Search Report EP 1548420 A3, regarding EP App. No. 04029883, dated Mar. 13, 2006, 4 pages.
  • Japanese Communication, with English translation, dated Feb. 5, 2013 in co-pending Japanese Patent Application No. JP 2011-179614.
  • Japanese communication , with English translation, dated Jul. 1, 2014 in co-pending Japanese patent application No. JP 2013-161276.
  • Extended European Search Report dated Dec. 21, 2010 in co-pending European Patent Application No. 08253748.1.
  • Japanese Communication, with English translation, dated Mar. 26, 2013 in co-pending Japanese Patent Application No. 2008-288424.
  • Japanese Communication, with English translation, dated Aug. 21, 2012 in co-pending Japanese patent application No. JP 2010-245357.
  • Japanese communication, with English translation, dated Feb. 18, 2014 in co-pending Japanese patent application No. JP 2013-032622.
  • English translation of Chinese Communication dated Aug. 29, 2012 in co-pending Chinese patent application No. CN 201010531386.0.
  • Chinese Communication, with English translation, dated Dec. 4, 2013 in co-pending Chinese patent application No. 2010105313860.
  • European communication dated Sep. 17, 2015 in co-pending European patent application No. 10189175.2.
  • Millipore's Initial Infringement Contentions, Document No. 19, filed Oct. 8, 2009 in the United States District Court for the District of Massachusetts, Civil Action No. 09-10765 DPW, 16 pages.
  • Gore's Preliminary Non-Infringement Contentions to Plaintiff Millipore Corporation, Document No. 20, filed Oct. 29, 2009 in the United States District Court for the District of Massachusetts, Civil Action No. 09-10765 DPW, 30 pages.
  • Gore's Preliminary Invalidity Contentions to Plaintiff Millipore Corporation, Document No. 21, filed Oct. 29, 2009 in the United States District Court for the District of Massachusetts, Civil Action No. 09-10765 DPW, 108 pages.
  • Memorandum and Order, Document No. 70, dated Sep. 20, 2010, in the United States District Court for the District of Massachusetts, Civil Action No. 09-10765-DPW, 59 pages.
  • Memorandum and Order Denying Millipore's Motion to Alter Judgment and for Reconsideration, U S District Court for the District of Massachusetts, EMD Millipore Corporation v. W. L. Gore & Associates, Inc., Civil Action No. 09-10765-DPW, Document 83, Dated Mar. 20, 2012, 16 pages.
  • File history of U.S. Trademark Application No. 78/140,217, filed Jul. 1, 2002, 53 pages.
  • File history of Provisional U.S. Appl. No. 60/375,747 (application filed Apr. 26, 2002), Document 53-2, Case 1:09-cv-10765-DPW, filed May 25, 2010, 50 pages.
  • File history of Provisional U.S. Appl. No. 60/500,024 (application filed Sep. 4, 2003), 23 pages.
  • Correspondence from T. Pender to C. Burrell dated Dec. 2, 2011 regarding C.A. No. 11-CV-346-SLR (Bates Stamp GF000001-GF000008), 8 pages.
  • Documents Produced by Third Party Casella Sales and Marketing Inc., Bates No. CSMI000001 through CSMI000066, 65 pages, Nov. 2011.
  • Fluid Line Technology Corporation Documents produced in Gore v. Millipore, Nov. 28, 2011, Bates # FLT000001 through Bates # FLT000103, 48 pages.
  • Gore's Prior Art Statement with Exhibits A through I (entire document), U S District Court for the District of Delaware, W. L. Gore & Associates, Inc. v. EMD Millipore Corporation, Civil Action No. 11-346-SLR, Dated Dec. 21, 2011, 55 pages.
  • Gore's First Supplemental Response to Millipore's First Set of Interrogatories [Interrogatory Nos. 11, 15 and 16] dated Nov. 1, 2011, United States District Court for the District of Delaware, Civil Action No. 11-346-SLR, 86 pages.
  • Gore's Third Supplemental Response to Millipore's First Set of Interrogatories [Interrogatory No. 11], Civil Action No. 11-346-SLR, United States District Court for the District of Delaware, dated Dec. 21, 2011, part 1—pp. 1-43; part 2—pp. 44-85 with Exhibits A-E (334 pages), Exhibits F-G (115 pages) and Exhibits H-I (114 pages). (Note due to the size limitations this is uploaded into 5 parts).
  • Gore's Fourth Supplemental Response to Millipore's First Set of Interrogatories [Interrogatories Nos. 11 and 12], Civil Action No. 11-346-SLR in the USDC for the District of Delaware, dated May 9, 2012, 172 pages.
  • Millipore's List of Claim Terms to Be Construed and Proposed Constructions, U S District Court for the District of Delaware, W. L. Gore & Associates, Inc. v. EMD Millipore Corporation, Civil Action No. 11-346-SLR, Dated May 30, 2012, 8 pages.
  • Gore's List of Claim Terms and Proposed Constructions, U S District Court for the District of Delaware, W. L Gore & Associates, Inc. v. EMD Millipore Corporation, Civil Action No. 11-346-SLR, Dated May 30, 2012, 4 pages.
  • Millipore's Responsive Constructions of Claim Terms, U S District Court for the District of Delaware, W. L. Gore & Associates, Inc. v. EMD Millipore Corporation, Civil Action No. 11-346-SLR, Dated Jun. 20, 2012, 5 pages.
  • Gore's List of Responsive Claim Constructions, U S District Court for the District of Delaware, W. L. Gore & Associates, Inc. v. EMD Millipore Corporation, Civil Action No. 11-346-SLR, Dated Jun. 27, 2012, 8 pages.
  • Gore's Motion for Leave to Amend Its Complaint for Declaratory Judgment, US District Court for the District of Delaware, W. L. Gore & Associates, Inc. v. EMD Millipore Corporation, Civil Action No. 11-346-SLR-MPT, Document 71, Dated Aug. 8, 2012, 3 pages.
  • Exhibits 1 and 2 to Gore's Motion for Leave to Amend Its Complaint for Declaratory Judgment, US District Court for the District of Delaware, W. L. Gore & Associates, Inc. v. EMD Millipore Corporation, Civil Action No. 11-346-SLR-MPT, Document 75, Redacted-Public Version, Dated Aug. 15, 2012, 241 pages.
  • Plaintiff Gore's Brief in Support of Motion for Leave to Amend Its Complaint for Declaratory Judgment, US District Court for the District of Delaware, W. L. Gore & Associates, Inc. v. EMD Millipore Corporation, Civil Action No. 11-346-SLR-MPT, Document 76, Dated Aug. 15, 2012, Redacted—Public Version, 23 pages.
  • Preliminary Noninfringement and Invalidity Disclosures of Allpure Technologies, Inc., Document 22, filed Jul. 20, 2011 in the United States District Court for the District of Massachusetts, Civil Action No. 11-cv-10221-DPW, 15 pages.
  • AESSEAL Environmental Technology P04U and PO5U Single Bellows Component Seal Range, Jan. 2006, (Exhibit 4 to the Affidavit of Alexander H. Slocum, Ph.D., US District Court for the District of Massachusetts, EMD Millipore Corporation v. AllPure Technologies, Inc., Civil Action No. 1:11-cv-10221-DPW,Document 66-4, dated May 2, 2012), 5 pages.
  • Purdue University—School of Mechanical Engineering—International Compressor Engineering Conference, article by J. W. Abar, “End Face Seals for Air-Conditioning Compressors”, 1972 (Exhibit 5 to the Affidiavit of Alexander H. Solcum, Ph.D, US District Court for the District of Massachusetts, EMD Millipore Corporation v. AllPure Technologies, Inc., Civil Action No. 1:11-cv-10221-DPW,Document 66-5, dated May 2, 2012), 15 pages.
  • Memorandum and Order regarding Claim Construction, U S District Court for the District of Massachusetts, EMD Millipore Corporation v. Allpure Technologies, Inc., Civil Action No. 11-10221-DPW, Document 81, Dated Oct. 11, 2012, 34 pages.
  • Allegheny Bradford Corporation's Objections and Responses to Subpoena, Civil Action No. 1:11-cv-00346-SLR, dated Dec. 15, 2011 in the USDC for the District of Delaware, and Bates # ABC00001 through Bates # ABC000012, 19 pages.
  • Photographs (7 photos) of the Millipore commercially needleless sampling device; available at least as of Feb. 14, 2012, 7 pages.
  • Photographs (3 photos) of the Millipore Opticap XLT base, commercially available in 2002, no earlier than Jan. 1, 2002, 3 pages.
  • Photographs (3 photos) of the Millipore Opticap XL 300, commercially available in 2002, no earlier than Jan. 1, 2002, 3 pages.
  • Brief for Plaintiff-Appellant, US Court of Appeals, Appeal Nos. 2011-1029, 2012-1371, EMD Millipore Corporation v. W. L. Gore & Associates, Inc., Document 40, dated Jul. 25, 2012 and filed Jul. 27, 2012 , 147 pages, submitted in 2 parts.
  • Brief of Defendant—Appellee W. L. Gore & Associates, Inc., US Court of Appeals, Appeal Nos. 2011-1029, 2012-1371, EMD Millipore Corporation v. W. L. Gore & Associates, Inc., Document 52, filed Oct. 9, 2012, 75 pages.
  • Reply Brief for Plaintiff—Appellant, US Court of Appeals, Appeal Nos. 2011-1029, 2012-1371, EMD Millipore Corporation v. W. L. Gore & Associates, Inc., Document 57, Dated Nov. 9, 2012, 42 pages.
  • About Fluid Line Technology, http://www/fluidlinetech.com/aboutus.html, dated May 8, 2012 and Oct. 30, 2009, 35 pages.
  • Allegro Single-use Systems—Recommended Capsule Filters and Membranes, http://www.pall.com/main/Biopharmaceuticals/Product.page?id-48022 and http://www.pall.com/variants/print/biopharm_48022.asp, dated May 8, 2012 and Oct. 30, 2009, 51 pages.
  • AllPure Takeone Aseptic Sampling System Overview, 2 pgs. (Deposition Exhibit dated Nov. 12, 2012).
  • Tingley, S., “Plastic factory: Disposable biopharmaceutical manufacturing takes a giant leap forward”, Alternative Manufacturing, Clean Rooms, pp. S4-S9, (Feb. 2003), 6 pages.
  • Tingley, S., “Plastic factory, Part II: The final pieces of the disposable puzzle”, Alternative Manufacturing, Clean Rooms, pp. 12-14 (Jun. 2003), 4 pages.
  • ASI Life Sciences, three 60, Single Use Aseptic Sampling System, www.asisus.com, Jan. 10, 2013, 8 pages.
  • Wendt, D., “BioTrends: Disposable Processing Systems: How Suppliers Are Meeting Today's Biotech Challenges from Fluid Handling to Filtration”, Biopharm International, p. 18 (Jul. 2003), 7 pages.
  • Haughney, H. and H. Aranha, “Disposable Processing Gains you a Competitive Edge: Enhancing Manufacturing Capacity with Disposable Filters, Connectors, and Membrane Chromatagraphy”, Biopharm International, p. 50 (Oct. 2003), 7 pages.
  • Casella Sales & Marketing Inc., CSMI Sample Valves. Datasheet [online]. Retrieved from the Internet: www.casellasales.com (2 pages), product offered online as early as Aug. 2008, according to URL search performed on http://web.archive.org.
  • Greene, R., et al., “Disposable Equipment: A Mainstay in Bioprocessing”, Chemical Engineering Progress, vol. 98, Issue 11, (Nov. 2002), 9 pages.
  • Haughney, H., et al., “Taking Disposable Processing to the Next Level”, Clean Rooms, (Jun. 2004), 5 pages.
  • Colder Products—Quick Couplings & Fittings for Industrial Applications—Industrial Products, http://www.colder.com/Markets/Industrial/IndustrialProducts/tabid/821/Default.aspx?ProductId=22, dated Oct. 30, 2009, 17 pages.
  • Daily Business Briefing—“Entegris Introduces the First All Teflon PFA/Process Tee Valve”, dated Apr. 16, 2002, 2 pages.
  • ESP Sanitary Sample Valves Operation and Maintenance Instructions dated Nov. 1995 (WLG-DEL00039664-WLG-DEL00039678), Millipore Corporation, 16 pages.
  • Entegris Impact Asymmetric Disposable Filters, Product Information brochure, 4414-5723ENT-0511, 2006, 6 pages.
  • Entegris Impact Mini Disposable Filters, Product Information brochure, 4414-2646ENT-1006, 2006, 4 pages.
  • Fluid Line Technology Corporation, FLT Bleed/Sample Valve Maintenance, Nov. 10, 2008. Datasheet [online], Fluid Line Technology. Retrieved from the Internet: www.fluidlinetech.com (1 page).
  • Sanitary Inline Bleed and Sample Valves. Datasheet [online], Fluid Line Technology, Retrieved from the Internet: www.fluidlinetech.com (1 page), document created on Mar. 2, 2009 according to document properties.
  • Fluid Line Technology Corporation, Product Catalog, 32 pages, Bates No. FLT000003-FLT000034, on information and belief available as of about Nov. 2009.
  • Gore Single-Use Valve, for Steam-in-Place Applications, 4 pgs. 2009.
  • Gore STA-PURE Fluid Sampling System, For Single-Use Aseptic Applications, Secure Sampling for Bioprocessing Fluids, Dec. 2008, 4 pages.
  • ITT Dualrange Control Valve. Data Sheet [online], Pure-Flo. Retrieved from the Internet: www. ittpureflo.com (2 pages), document created Jan. 12, 2007 according to document properties.
  • ITT Sample & Bleed Valves. Datasheet [online], ITT Corporation, 2006. Retrieved from the Internet: www.ittpureflo.com (4 pages).
  • Block, S.S., Disinfection, Sterilization, and Preservation (Fourth Edition), Chapter 11, Alcohols, pp. 191-203, by Larson, et al., Lea & Febiger, ISBN:0-8121-1364-0, 1991 (only the year was cited on the publication), 15 pages.
  • Lynx ST Connectors http://www.millipore.com/catalogue/module/c9131 dated Oct. 30, 2009, 9 pages.
  • Lynx ST Connectors, Millipore Data Sheet, Lit. No. 051750EN00, Rev. E, May 2008, 4 pages.
  • Lynx Trademark Reg. No. 2,831,931, first use Apr. 1, 2003, registered Apr. 13, 2004, 3 pages.
  • Guidelines for Using the Lynx ST Connector. Technical Brief [online], Millipore Corporation, 2008. Retrieved from the Internet: www/millipore.com (2 pages).
  • International Application No. PCT/US03/13073, filed Apr. 25, 2003, and Request for Express Abandonment of U.S. Appl. No. 10/423,131, filed Sep. 11, 2003, 56 pages.
  • Microbiological Analysis (Sampling Equipment)—Sampling Ports, p. 130, 1989 (only the year is available for this publication).
  • MicropreSure Sanitary Sampling Valves, Millipore Data Sheet, Lit. No. DS1006EN00, May 2005, 4 pages.
  • “Connecting the Sanitary Flange,” Datasheet [online], Millipore Corporation, 2007 (pp. 1-2).
  • Millipore Express SHF Hydrophilic Cartridge Filters, Data Sheet, May 16, 2013, www.millipore.com/catalogue, 2 pages.
  • Millipore, Hydrophilic Durapore Cartridges and Capsules User Guide, Lit. No. RF 1510EN00, Jan. 2002, 56 pages.
  • Millipore, Milliflex-P Sanitary Sampling Valves, Operation and Maintenance Instructions, Jul. 2006, 17 pages.
  • Millipore Corporation, Milli-Q Direct Water Purification System brochure, Lit. No. PB1032EN00, Jan. 2012, 8 pages.
  • Millipore Corporation, Milli-Q Advantage A10 Water Purification Systems brochure, Lit. No. PB0001EN00, 2013, 12 pages.
  • NovAseptic—How to Use NA sampling system, http://www.novaseptic.se/main.asp?typ=6, dated Feb. 13, 2002, 2 pages.
  • NovAseptic, Novaseptum Liquid Sampling System—Totally Enclosed System/ No Cross Contamination/ Presterilized Disposable Unit/ Pyrogen Free, p. 1-4, Feb. 2003.
  • Millipore Publication, NovAseptic, NovaSeptum Liquid Sampling System, dated Nov. 2001, P75185, Rev. B (Bates stamp—WLG-DEL00040809-WLG-DEL00040813), 6 pages.
  • NovaSeptum sampling systems, EMD Millipore Data Sheet, Jun. 2012, Lit. # DS0050EN00, Rev. E., 10 pgs.
  • NovaSeptum sampling systems, Merck Millipore Data Sheet, Apr. 2013, Lit. # DS0050EN00, Rev. H., 10 pgs.
  • Millipore, NovaSeptum AV Sterile Sampling System, for liquid sampling, User Guide, Lit. No. 00000069TP, Rev. A., Jun. 2006, 2 pages.
  • Opticap Valve: Millipore Application Note, Jul. 2000, “Gamma Compatible Sterilizing Grade Filter Capsules for Use with Disposable Manufacturing Containers”; 6-pages.
  • Opticap Vent; Millipore Data Sheet, Apr. 2005, “Gamma Compatible Sterilizing-grade Durapore 0.1 um and 0.22 um Filters”, 8-pages.
  • Opticap3; Millipore Corporation, Nov. 2001, “Opticap TM Capsules with Millistak+™. Media User Guide”, 4-Pages.
  • Millipore Opticap XL and XLT Disposable Capsules, Millipore Corporation, Lit. No. PB1700EN00, Rev. B, Jun. 2004, 4 pages.
  • Pharmaceutical Engineering, vol. 23, No. 3, May/Jun. 2002, pp. 1-8, “Single-Use Disposable Filling for Sterile Pharmaceuticals”, Belongia, et al.
  • Janetschek, R., “Capsule Filters & Disposable Sterile Processing Systems”, Pharmaceutical Processing, vol. 18, No. 11, p. 8 (Jan. 2001), 4 pages.
  • “New quality of data for bioprocessing bags. (Application Area).” Pharmaceutical Processing, Jan. 2002, Charter Medical, Ltd., Bioprocess Products, Retrieved from the Internet on Feb. 16, 2010 from accessmylibrary: <URL: http://www.accessmylibrary.com/coms2/summary_0286-25022745_ITM>, pp. 1-2.
  • Pharmenta AptiPort Sampling Valve, http://www.web.archive.org/web/20031029084907/http://www.pharmenta.com/aptiport.htm, 1 page, last modified Mar. 29, 2004, retrieved from internet May 8, 2012.
  • Landon, R., et al., “Bridging the Gap: A case study in the validation of hybrid connectors”, Process PharmaTEC International, issue Jun. 2004 (RP1007EN00), pp. 16-17, Nov. 2004, 3 pages.
  • ITT, Pure-Flo Hygienic diaphragm valves, actuators, and switch packages, http://www.ittpureflo.com/valvetype.html dated May 8, 2012 and Oct. 30, 2009, 12pages.
  • Pure-Flo: Sample and Bleed Valves for the pharmaceutical and bioprocessing industries, dated Sep. 1992, ITT Fluid Tech. Corp., (Bates stamp WLG=DEL00039389-WLG-DEL00039394), 6 pages.
  • Pure-Flo Solutions, Pure-Flo Radial Seated Tank Bottom Diaphragm Valve, Datasheet [online], ITT Industries, 2001 (only the year was cited on the publication), (2 pages).
  • Redacted email, dated Jun. 4, 2012, regarding Disposable Steam Connector, 2 pages.
  • Risk Free Connection of Sterilized Single-Use Fluid Path Assemblies to Stainless Steel SIP Systems with Lynx ST (Steam-To) Connectors [online], Millipore Corporation Application Note, Rev. A, Lit. No. AN7428EN00, May 2008. Retrieved from the Internet: www.millipore.com (8 pages).
  • Sani-Tech Globe & Angle Valve product information, dated Aug. 1989 (Bates stamp WLG-DEL00040302-WLG-DEL00040304), 3 pages.
  • Millipore, Series 2000, Single Sanitary Cartridge Housing, Instructions for Installation and Maintenance, Lit. No. P35265, Rev. A, Feb. 2000, 12 pages.
  • “Sip-Able Sample Valve,” Datasheet [online]. Retrieved from the Internet: www.fluidlinetech.com (1 page), product offered online as early as Jun. 26, 2007, according to URL search performed on http://web.archive.org.
  • Steam-in-Place Bag Connector, http://www.fluidcomponents.net/tc_tech.html, download on Feb. 18, 2010, 1 page.
  • “Rapid Aseptic Fluid Transfer System Introduction” Stedim Blosystems. [online]. Retrieved from the Internet: <URL: http: www.stedim.com/p2A_IDC_introduction.php> (2 pages), dated Nov. 21, 2007.
  • ThermoScientific, Data Sheet 053, Rev. 2, “Aseptic Connection Devices”, 2008, 2 pages.
  • Valves, Gemu Valves and Distributor, Diaphragm Valves, Sanitary Valves, Aseptic Valves, Valves and Fittings, Casella Sales and Marketing, Inc., http://www.casellasales.com, dated May 8, 2012 and Oct. 30, 2009, 13 pages.
  • Waukesha Cherry-Burrell Manual Valves, dated May 2000 (Bates stamp CSMI000044-CSMI000066), 23 pages.
  • Office action dated Mar. 9, 2016 in co-pending U.S. Appl. No. 13/972,301.
  • Office action dated Apr. 4, 2016 in co-pending U.S. Appl. No. 13/972,301.
  • Office action dated Apr. 18, 2014 in related U.S. Appl. No. 14/040,777.
  • Office action dated Mar. 20, 2015 in co-pending U.S. Appl. No. 13/827,747.
  • Final rejection dated Oct. 7, 2015 in co-pending U.S. Appl. No. 13/827,747.
  • Office action dated Jun. 1, 2016 in co-pending U.S. Appl. No. 13/827,747.
  • Office action dated Dec. 23, 2016 in co-pending U.S. Appl. No. 13/827,747.
  • Final rejection dated Jun. 28, 2017 in co-pending U.S. Appl. No. 13/827,747.
  • European communication dated Nov. 17, 2017 in co-pending European patent application No. 10189175.2.
  • Office action dated Feb. 1, 2018 in co-pending U.S. Appl. No. 13/827,747.
  • Final rejection dated Aug. 24, 2018 in co-pending U.S. Appl. No. 13/827,747.
  • Office action dated Jan. 22, 2019 in co-pending U.S. Appl. No. 13/827,747.

Patent History

Patent number: 10247312
Type: Grant
Filed: Mar 28, 2016
Date of Patent: Apr 2, 2019
Patent Publication Number: 20160208927
Assignee: EMD Millipore Corporation (Burlington, MA)
Inventors: Jeff Hartnett (West Roxbury, MA), Alf Lofving (Torslanda), Lars Hultquist (Alvangen), Jan Davidsson (Kode), Lennart Myhrberg (Alvangen)
Primary Examiner: Marina Tietjen
Application Number: 15/082,495

Classifications

Current U.S. Class: With Leakage Or Drip Collecting (137/312)
International Classification: F16K 1/12 (20060101); F16K 31/528 (20060101); A61M 39/22 (20060101); F04B 39/00 (20060101);